Job Description

Job – Systems Engineer – Verification & Validation (Medical Devices)

Location: Tucson AZ – Hybrid

Duration: 18 Months

Position Overview

The Systems Engineer I will be part of the R&D team , responsible for requirements definition , risk management , and verification & validation (V&V) across the product lifecycle. The role requires collaboration across departments to ensure compliance with regulatory standards and customer needs .

Key Responsibilities

• System Lifecycle Management: Apply systems engineering practices focusing on requirements engineering , risk mitigation , and V&V .
• Industry and Technology Analysis: Monitor industry trends and emerging technologies to enhance project outcomes.
• Cross-functional Collaboration: Work closely with R&D , Marketing , Operations , Quality , and Regulatory teams.
• Customer-Focused Innovation: Align technical solutions with customer needs through Voice of the Customer (VoC) inputs.
• Technical Problem Solving: Present solution paths and tradeoffs to address complex engineering challenges.
• Project Execution: Manage and execute deliverables related to requirements , risk analysis , configuration management , defect tracking , and V&V using internal tools.

Required Qualifications

• Bachelor’s degree in Engineering, Biomedical Sciences, or related field with 4 years of experience , or
• Master’s degree with 2 years of experience , or PhD .
• Strong knowledge of systems engineering principles :
• Requirements engineering
• Risk analysis & mitigation
• Verification & validation
• Configuration management
• Experience working in regulated environments ( FDA , ISO ) with diagnostic products.
• Demonstrated strategic thinking and problem-solving abilities.

Preferred Qualifications

• Proficiency in requirements elicitation and FMEA (Failure Mode and Effects Analysis) .
• Experience with usability engineering and V&V strategy development .
• Strong communication and leadership skills for team facilitation.
• Excellent organizational skills to manage multiple projects and complex documentation (e.g., risk registers , V&V matrices ).
• Familiarity with assay development and related regulatory needs.
• Experience with tools like RETINA , LucidSpark , and LucidChart .
• Advanced understanding of software engineering , electronics , electromechanical systems , IT , and basic chemistry .

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